AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer

Radioimmunoassay, Thyroid-stimulating Hormone

BODITECH MED INC.

The following data is part of a premarket notification filed by Boditech Med Inc. with the FDA for Afias Tsh-sp, Afias Tsh-vb, Afias-6/sp Analyzer, Afias-6/vb Analyzer.

Pre-market Notification Details

Device IDK170232
510k NumberK170232
Device Name:AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant BODITECH MED INC. 43, GEODUDANJI 1-GIL, DONGNAE-MYEON Chuncheon-si,  KR
ContactHyung-ju Oh
CorrespondentHyung-ju Oh
BODITECH MED INC. 43, GEODUDANJI 1-GIL, DONGNAE-MYEON Chuncheon-si,  KR
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-25
Decision Date2017-10-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886133010075 K170232 000
08806133010075 K170232 000
08806133005279 K170232 000
08806133005262 K170232 000

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